Chidamide in Combination With DCAG With or Without Venetoclax for Relapsed/Refractory Acute Myeloid Leukemia

IF 3.1 2区医学 Q2 ONCOLOGY

Cancer Medicine Pub Date : 2025-03-10 DOI:10.1002/cam4.70734

Qingyang Liu, Xiawei Zhang, Lei Lv, Linming Xu, Yu Jing, Wenjing Gao, Lili Wang, Liping Dou

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引用次数: 0

Abstract

Introduction

Currently, there are only a few avaailable treatment options for patients with relapsed and refractory acute myeloid leukemia (R/R AML).

Methods

We conducted a single-center, phase 1 prospective study (ChiCTR2200065634) to evaluate the efficacy and safety of chidamide, demethylating drugs (azacitidine), cytarabine, aclacinomycin, and G-CSF plus venetoclax (CDCAG-VEN) in patients with R/R AML. The previous CDCAG regimen was used as a historical control to compare its efficacy and safety. Thirty and 22 patients received one course of CDCAG with or without a 14-day course of venetoclax, respectively.

Results

The overall response rate (ORR) was significantly higher in the CDCAG-VEN group than in the CDCAG-treated group (78.6% vs. 45.5%; p = 0.015), and the CDCAG-VEN group achieved a better trend of measurable residual disease-negative response (61.1% vs. 22.2%, p = 0.134). Compared with the CDCAG group, the CDCAG-VEN group exhibited significantly better 1-year overall survival (63.3% vs. 35.1%, p = 0.005) and progression-free survival (76.7% vs. 36.0%, p = 0.022). The duration of response was notably better in the CDCAG-VEN group than in the CDCAG group (71.2% vs. 34.3%, p = 0.021) and had a lower cumulative incidence of relapse (22.2% vs. 48.9%, p = 0.095). The neutrophil and platelet recovery times were similar between the CDCAG-VEN and CDCAG groups (neutrophil: 18 days vs. 19 days, p = 0.293; platelet: 18 days vs. 19 days, p = 0.311). The frequencies of adverse events were comparable between both groups, except for a lower incidence of thrombosis in the CDCAG-VEN group (0% vs. 22.7%, p = 0.006).

Discussion

In conclusion, venetoclax in combination with CDCAG is an effective and safe treatment regimen for R/R AML, thereby rapidly identifying chemosensitive patients and inducing measurable residual disease-negative remission in a high proportion of patients with R/R AML.

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奇达胺联合DCAG治疗复发/难治性急性髓系白血病

目前，对于复发和难治性急性髓性白血病（R/R AML）患者，只有少数可用的治疗方案。方法：我们开展了一项单中心、1期前瞻性研究（ChiCTR2200065634），评估奇达胺、去甲基化药物（阿扎胞苷）、阿糖胞苷、阿克拉霉素和G-CSF + venetoclax （CDCAG-VEN）治疗R/R AML患者的疗效和安全性。既往CDCAG方案作为历史对照，比较其疗效和安全性。30例和22例患者分别接受了一个疗程的CDCAG治疗，同时或不接受14天的venetoclax治疗。结果CDCAG-VEN组总有效率（ORR）显著高于cdcag -治疗组(78.6% vs 45.5%；p = 0.015)， CDCAG-VEN组可测量的残留疾病阴性反应趋势更好（61.1%比22.2%,p = 0.134）。与CDCAG组相比，CDCAG- ven组的1年总生存率（63.3% vs. 35.1%, p = 0.005）和无进展生存率（76.7% vs. 36.0%, p = 0.022）显著提高。CDCAG- ven组的缓解时间明显优于CDCAG组（71.2% vs. 34.3%, p = 0.021），且累积复发率较低（22.2% vs. 48.9%, p = 0.095）。CDCAG- ven组和CDCAG组的中性粒细胞和血小板恢复时间相似(中性粒细胞：18天vs. 19天，p = 0.293；血小板：18天vs. 19天，p = 0.311)。除了CDCAG-VEN组血栓发生率较低（0%比22.7%,p = 0.006）外，两组之间不良事件的频率具有可比性。总之，venetoclax联合CDCAG治疗R/R AML是一种有效且安全的治疗方案，可以快速识别化疗敏感患者，并在很大比例的R/R AML患者中诱导可测量的残留疾病阴性缓解。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Cancer Medicine ONCOLOGY-

CiteScore

5.50

自引率

2.50%

发文量

907

审稿时长

19 weeks

期刊介绍： Cancer Medicine is a peer-reviewed, open access, interdisciplinary journal providing rapid publication of research from global biomedical researchers across the cancer sciences. The journal will consider submissions from all oncologic specialties, including, but not limited to, the following areas: Clinical Cancer Research Translational research ∙ clinical trials ∙ chemotherapy ∙ radiation therapy ∙ surgical therapy ∙ clinical observations ∙ clinical guidelines ∙ genetic consultation ∙ ethical considerations Cancer Biology: Molecular biology ∙ cellular biology ∙ molecular genetics ∙ genomics ∙ immunology ∙ epigenetics ∙ metabolic studies ∙ proteomics ∙ cytopathology ∙ carcinogenesis ∙ drug discovery and delivery. Cancer Prevention: Behavioral science ∙ psychosocial studies ∙ screening ∙ nutrition ∙ epidemiology and prevention ∙ community outreach. Bioinformatics: Gene expressions profiles ∙ gene regulation networks ∙ genome bioinformatics ∙ pathwayanalysis ∙ prognostic biomarkers. Cancer Medicine publishes original research articles, systematic reviews, meta-analyses, and research methods papers, along with invited editorials and commentaries. Original research papers must report well-conducted research with conclusions supported by the data presented in the paper.